"The review concluded that the study was designed in compliance with The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidances, country-specific regulatory requirements (e.g. FDA, DEA, TGA) and appropriate ethics committees’ approvals.
The statistical review and additional analyses conducted did not uncover any trends or deficiencies in the data set that could explain the unusually higher vehicle response in the US. "
Looking Forward to a GREAT 2020, page-484
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